Application Nr Approved Date Route Status External Links
ANDA203088 2014-06-11 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Duloxetine Delayed-Release Capsules Is A Serotonin And Norepinephrine Reuptake Inhibitor (snri) Indicated For: Major Depressive Disorder (mdd) ( ) 1.1 Generalized Anxiety Disorder (gad) ( ) 1.2 Diabetic Peripheral Neuropathic Pain (dpnp) ( ) 1.3 Chronic Musculoskeletal Pain ( ) 1.5 1.1 Major Depressive Disorder Duloxetine Delayed-Release Capsules Are Indicated For The Treatment Of Major Depressive Disorder (mdd). The Efficacy Of Duloxetine Delayed-Release Capsules Was Established In Four Short-Term And One Maintenance Trial In Adults . [see ] Clinical Studies (14.1) A Major Depressive Episode (dsm-Iv) Implies A Prominent And Relatively Persistent (nearly Every Day For At Least 2 Weeks) Depressed Or Dysphoric Mood That Usually Interferes With Daily Functioning, And Includes At Least 5 Of The Following 9 Symptoms: Depressed Mood, Loss Of Interest In Usual Activities, Significant Change In Weight And/or Appetite, Insomnia Or Hypersomnia, Psychomotor Agitation Or Retardation, Increased Fatigue, Feelings Of Guilt Or Worthlessness, Slowed Thinking Or Impaired Concentration, Or A Suicide Attempt Or Suicidal Ideation. 1.2 Generalized Anxiety Disorder Duloxetine Delayed-Release Capsules Are Indicated For The Treatment Of Generalized Anxiety Disorder (gad). The Efficacy Of Duloxetine Delayed-Release Capsules Was Established In Three Short-Term Trials And One Maintenance Trial In Adults . [see ] Clinical Studies (14.2) Generalized Anxiety Disorder Is Defined By The Dsm-Iv As Excessive Anxiety And Worry, Present More Days Than Not, For At Least 6 Months. The Excessive Anxiety And Worry Must Be Difficult To Control And Must Cause Significant Distress Or Impairment In Normal Functioning. It Must Be Associated With At Least 3 Of The Following 6 Symptoms: Restlessness Or Feeling Keyed Up Or On Edge, Being Easily Fatigued, Difficulty Concentrating Or Mind Going Blank, Irritability, Muscle Tension, And/or Sleep Disturbance. 1.3 Diabetic Peripheral Neuropathic Pain Duloxetine Delayed-Release Capsules Are Indicated For The Management Of Neuropathic Pain (dpnp) Associated With Diabetic Peripheral Neuropathy . [see ] Clinical Studies (14.3) 1.5 Chronic Musculoskeletal Pain Duloxetine Delayed-Release Capsules Are Indicated For The Management Of Chronic Musculoskeletal Pain. This Has Been Established In Studies In Patients With Chronic Low Back Pain (clbp) And Chronic Pain Due To Osteoarthritis . [see ] Clinical Studies (14.5)

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Hypromelloses HYPROMELLOSES Unresolved
3. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
4. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Shellac SHELLAC Unresolved
7. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Duloxetine Hydrochloride DULOXETINE HYDROCHLORIDE ZINC1536779

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